Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy

March 7, 2011 updated by: Roswell Park Cancer Institute

Calcitriol + Dexamethasone in Early, Recurrent Prostate Cancer Following Local Therapy, A Phase I/II Trial

RATIONALE: Calcitriol may help tumor cells develop into normal cells. Dexamethasone may increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining calcitriol with dexamethasone in treating patients with prostate cancer who have undergone surgery or radiation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine whether calcitriol and dexamethasone can slow the rise in prostate-specific antigen (PSA) levels in patients with early, recurrent prostate cancer after prior radical prostatectomy or radiotherapy.
  • Determine the safety of this regimen in these patients.
  • Determine the utility of serum PSA in monitoring the therapeutic effect of calcitriol in these patients.

OUTLINE: Patients are stratified according to prior therapy (radical prostatectomy vs radiotherapy).

Patients receive oral calcitriol once daily on days 1-3 alone on week 1. Beginning on week 3, patients receive calcitriol as in week 1 and oral dexamethasone on days 0-4. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 56 patients (28 per stratum) will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Hillman Cancer Center at University of Pittsburgh Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate meeting all of the following criteria:

    • Curatively treated with radical prostatectomy OR definitive radiotherapy
    • No signs of clinical recurrence or dissemination of prostate cancer by digital rectal examination without tumor
    • No local recurrence by CT scan or MRI of the pelvis
    • No metastases by bone scan and chest x-ray NOTE: Prior Prostascint scans allowed regardless of results

  • At least 3 prostate-specific antigen (PSA) measurements obtained over at least 90 days after radical prostatectomy on post-radiotherapy PSA nadir must be available

    • PSA at least 2 ng/mL after prostatectomy OR at least 4 ng/mL after prior radiotherapy
    • Patients previously treated with radiotherapy must have a PSA clearly rising from lowest value within 6 months after completion of therapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 12 months

Hematopoietic

  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN)
  • Alkaline phosphatase no greater than 2 times ULN

Renal

  • Creatinine less than 1.8 mg/dL
  • Phosphorus normal
  • No hypercalcemia (albumin-corrected calcium greater than ULN)

  • No nephrolithiasis

    • Single episode of renal lithiasis allowed provided episode occurred more than 5 years prior to study

Other

  • Fertile patients must use effective double-barrier contraception for at least 1 week before, during, and for at least 2 weeks after study
  • No symptomatic pancreatitis
  • No uncontrolled diabetes
  • No known or suspected inability to comply with study requirements (e.g., abuse of alcohol/drugs or psychotic states)
  • Curatively treated condition associated with renal stones (e.g., hyperparathyroidism, bladder dysfunction, or obstructive uropathy) allowed provided patient has been free of stone formation for more than 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for prostate cancer
  • At least 24 months since prior chemotherapy for other diseases

Endocrine therapy

  • More than 6 months since prior hormonal therapy, including neoadjuvant or adjuvant androgen deprivation therapy (e.g., luteinizing hormone-releasing hormone analogue or antiandrogen)
  • No prior androgen deprivation therapy of more than 8 months duration
  • No prior hormonal therapy for prostate cancer more than 3 months after definitive local therapy
  • No concurrent androgen therapy

Radiotherapy

  • See Disease Characteristics
  • More than 3 months since prior radiotherapy for locally recurrent prostate cancer
  • No concurrent radiotherapy, including for pain control

Surgery

  • See Disease Characteristics

Other

  • More than 4 weeks since prior investigational drugs

  • No concurrent medication known to affect systemic calcium metabolism, including any of the following:

    • More than 400 IU of cholecalciferol supplements
    • More than 500 IU of vitamin A supplements
    • Calcium supplements
    • Fluoride
    • Antiepileptics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roswell Park Cancer Institute

Investigators

  • Study Chair: Donald L. Trump, MD, Roswell Park Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

February 5, 2003

First Submitted That Met QC Criteria

February 5, 2003

First Posted (Estimate)

February 6, 2003

Study Record Updates

Last Update Posted (Estimate)

March 8, 2011

Last Update Submitted That Met QC Criteria

March 7, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000270758
  • RPCI-RP-0203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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